A Research Study Looking at Long-term Blood Sugar Control in People With Type 2 Diabetes Being Treated With Xultophy® in a Real-world Setting in Italy

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Prospective, Non-interventional, Single Arm Study Investigating Long-term Glycaemic Control in Patients With Type 2 Diabetes Initiating Xultophy® (IDegLira) in a Realworld Setting in Italy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666987
• Other study ID #: NN9068-4740
• Secondary ID: U1111-1253-1809
• Status: Completed
• Start date: October 21, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to collect information on how Xultophy® works in patients like them with type 2 diabetes. Participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 18 months. Participants will be asked questions about their health and diabetes treatment as part of the normal study doctor's appointment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: February 10, 2023
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained before any study-related activities (study-related activities include any procedure related to recording of data according to the protocol).

• Male or female, age greater than or equal to 18 years at the time of signing informed consent.

• Patient diagnosed with T2D greater than or equal to 12 months prior to signing informed consent.

• The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

• Treated with basal insulin with or without use of oral antidiabetics (OADs), with or without use of bolus insulin prior to initiating Xultophy®.

• For patients transferring from a regimen including bolus insulin, upon initiation of Xultophy® the bolus insulin component of the treatment regimen was stopped.

• The patient initiated Xultophy® treatment for at least 2 months, but no more than 3 months prior to signing informed consent.

• Available and documented HbA1c measurement no more than 3 months prior to Xultophy® initiation.

Exclusion Criteria:

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

• Diagnosed with type 1 diabetes mellitus, maturity-onset diabetes of the young, latent autoimmune diabetes in adults, gestational diabetes or any hyperglycaemic state other than T2D.

• Women known to be pregnant or breastfeeding, or women planning to become pregnant during the conduct of the study.

• Previous participation in this study. Participation is defined as having given informed consent in this study.

• Participation in another T2D clinical study that involves any clinical intervention or administration of an investigational drug within 3 months prior to enrolment into the study.

• Any contraindications for Xultophy®, including hypersensitivity to the active substances or any of the excipients as specified in the Xultophy® local label.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin degludec and liraglutide (IDegLira)
Paricipants will be treated with commercially available Xultophy® according to routine clinical practice at the discretion of the treating physician, following approved label in Italy. The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.

Locations

Country	Name	City	State
Italy	A.O. SS Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	INRCA	Ancona
Italy	Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato	Arezzo
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	ASST OSpedali Civili ad indirizzo Metabolico Diabetologico	Brescia
Italy	Centro Polispecialistico Asl Toscana Nord Ovest	Carrara
Italy	D.S. 43 Casoria Asl Napoli 2 Nord	Casoria
Italy	H Cannizzaro Malattie endocrine e del ricambio e nutrizione	Catania
Italy	Ospedale S. Maria del Prato	Feltre
Italy	A.O.U. Ospedali Riuniti	Foggia
Italy	Ospedale Camberlingo	Francavilla Fontana
Italy	Ospedale Policlinico San Martino	Genova
Italy	Ospedale Santa Maria Goretti - UOD Diabetologia	Latina	LT
Italy	A.O.U. Policlinico Martino	Messina
Italy	ASL Napoli 3 sud	Napoli
Italy	PSP Loreto Crispi	Napoli
Italy	Ospedale San Francesco d'Assisi	Oliveto Citra
Italy	Azienda Ospedaliera Padova	Padova
Italy	ICS Maugeri	Pavia	Pv
Italy	AUSL Pescara	Pescara
Italy	Ospedale San Jacopo	Pistoia
Italy	P.O. Praia a Mare ASP Cosenza	Praia a Mare
Italy	Casa della Salute Antistio	Roma
Italy	Policlinico Umberto I Clinica Medica DH Diabetologia	Roma
Italy	Policlinico Universitario AGemelli DH Patologie dell'Obesità	Rome
Italy	A.O.U. San Giovanni di Dio e Ruggi d'Aragona	Salerno
Italy	Ospedale San Donà di Piave	San Donà di Piave
Italy	ASUFC Udine	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin (HbA1c)	Percent (%) point; Baseline is defined as the time of Xultophy® initiation (V0); if the endpoint variable is unavailable at (V0), the most recent value within 3 months prior to Xultophy® initiation will be used.; (This definition of baseline applies to all outcome measures.)	From baseline (V0, month 0) to 6 months after initiation.
Secondary	Change in HbA1c		From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
Secondary	HbA1c levels less than 7% (yes/no)	Percentage of patients - yes	At end of study (V3, 18 ±3 months)
Secondary	HbA1c levels less than 7% without hypoglycaemic episodes (yes/no)	Percentage of patients - yes	At end of study (V3, 18 ±3 months)
Secondary	Reason for switching to Xultophy® (precoded question list)	Percentage of patients	At baseline (V0, month 0)
Secondary	Change in Xultophy® daily dose	Dose steps/day	From baseline (V0, month 0) to end of study (V3, 18 ±3 months)
Secondary	Number of self-reported non-severe hypoglycaemia episodes (defined as an episode with symptoms and/or self monitored blood glucose (SMBG) value less than or equal to 3.9 mmol/L) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Secondary	Number of self-reported nocturnal nonsevere hypoglycaemic episodes (defined based on the patient's perception of whether or not it was night) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Secondary	Number of self-reported severe hypoglycaemic episodes (Defined as an episode of hypoglycaemia requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective action) based on recollection	Number of episodes	Reported at enrolment (V1 - month 0), intermediate visits (V2.X - 0-17 months) and at end of study (V3, 18 ±3 months). Number of episodes occurring in the 4 weeks prior to study visit
Secondary	Treatment intensification (addition of prandial insulin, increase in total insulin dose or number of concomitant oral antidiabetics (OADs)) (yes/no)	Percentage of patients with treatment intensification	At end of study (V3, 18 ±3 months)
Secondary	Treatment simplification (decrease in insulin dose or number of concomitant OADs) (yes/no)	Percentage of patients with treatment simplification	At end of study (V3, 18 ±3 months)